{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-09-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "213809",
      "product_res_number": "Z-2018-2025",
      "event_date_initiated": "2025-05-28",
      "event_date_posted": "2025-06-24",
      "recall_status": "Open, Classified",
      "res_event_number": "96858",
      "product_code": "DRY",
      "k_numbers": [
        "K234065"
      ],
      "product_description": "CDI OneView System BPM Probe:\n\nCat. No. CDI753 - CDI OneView BPM Probe,\nCat. No. CDI753TK - CDI OneView BPM Probe Trial Kit",
      "code_info": "UDI-DI 00886799001889\n\nLot Number/Serial Number Range:\nB0050231-B0050240\nB0050221-B0050230\nB0050211-B0050219\nB0050201-B0050209\nB0050191-B0050200",
      "firm_fei_number": "1828100",
      "recalling_firm": "Terumo Cardiovascular Systems Corporation",
      "address_1": "6200 Jackson Rd",
      "city": "Ann Arbor",
      "state": "MI",
      "postal_code": "48103-9586",
      "additional_info_contact": "Terumo CVS Customer Service\n800-521-2818",
      "reason_for_recall": "Due to an error in assembly of the thermistor within some units, the affected probes will experience inaccuracy in measured shunt sensor temperature. Additionally, following changes in patient temperature without an in vivo recalibration, affected probes may experience inaccuracy in other measured parameters, including pCO2, pO2, pH, Potassium and calculated parameters, including BE, Bicarbonate, Arterial Oxygen Saturation, Delivered Oxygen, Area Under of the Curve of Delivered Oxygen, Oxygen Consumption, and Oxygen Extraction Ratio, which utilize temperature as an input. Inaccurate data may lead to inappropriate user response.",
      "root_cause_description": "Employee error",
      "action": "On May 28, 2025, firm began notifying affected consignees via Urgent Medical Device Removal letters.\n\nA Terumo Service Representative will contact each customer to discuss removal and replacement of affected devices. The firm is not recommending that customers halt use of their CDI OneView BPM Probe while waiting for removal and replacement. In the event suspected parameter inaccuracy occurs, performance of an in vivo recalibration is recommended. Per the Operator's Manual, displayed values should be verified for accuracy from another source before initial treatment.",
      "product_quantity": "28 US; 7 OUS",
      "distribution_pattern": "US Nationwide distribution in the states of California, Delaware, Hawaii, Iowa, Indiana, Michigan, North Carolina, New York, Ohio, and Washington. The country of New Zealand.",
      "openfda": {
        "k_number": [
          "K202557",
          "K931968",
          "K071725",
          "K881006",
          "K874839",
          "K001388",
          "K123039",
          "K903729",
          "K862953",
          "K062468",
          "K862069",
          "K852124",
          "K091908",
          "K843709",
          "K103168",
          "K941922",
          "K871686",
          "K955380",
          "K012743",
          "K811391",
          "K973472",
          "K831225",
          "K182110",
          "K202154",
          "K110957",
          "K955379",
          "K900682",
          "K854357",
          "K163657",
          "K234065",
          "K133658",
          "K900459",
          "K972962",
          "K821159",
          "K181923",
          "K980732",
          "K915265",
          "K823359",
          "K072131",
          "K843538",
          "K915255",
          "K871221",
          "K910421",
          "K090147",
          "K133157",
          "K173591",
          "K861277"
        ],
        "registration_number": [
          "1828100",
          "3000126629",
          "3011560054",
          "2029275",
          "1319639",
          "3044156918",
          "1928237",
          "9617601",
          "3006073153",
          "1118880",
          "2184009",
          "2011171",
          "1124841",
          "3002807090",
          "3002807561",
          "3019807891",
          "9611109",
          "9680841",
          "1218950",
          "3016618143",
          "2245590"
        ],
        "fei_number": [
          "1828100",
          "3000126629",
          "3011560054",
          "3044156918",
          "1928237",
          "3006073153",
          "3000204839",
          "1118880",
          "1000116158",
          "2011171",
          "1000306431",
          "1000138054",
          "3002534070",
          "3002807561",
          "3005426550",
          "3019807891",
          "1218950",
          "3016618143",
          "3006003617",
          "2245590",
          "3002808267"
        ],
        "device_name": "Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4330",
        "device_class": "2"
      }
    }
  ]
}